The duties of pharmacist in charge or delegate of a company, establishment or organisation mentioned in article R. 5124-2 are incompatible with the running of a pharmacy or the management of a mutualist pharmacy or a pharmacy of a mining relief society.
By way of derogation from article R. 5124-32, pharmacists and companies who own a pharmaceutical manufacturing establishment attached to their pharmacy by virtue of an authorisation to open obtained before the date of 13 February 1998 may continue to operate the said establishment at the same time as their pharmacy as long as they continue to own the latter. The pharmacists and companies mentioned in the previous paragraph are subject…
The responsible pharmacist is : 1° In the companies referred to in article L. 5124-2 : a) In public limited companies other than those governed by articles L. 225-57 et seq. of the Commercial Code, the Chairman of the Board of Directors who is the Chief Executive Officer, the Chief Executive Officer or a Deputy Chief Executive Officer; b) In sociétés anonymes governed by these articles, either the Chairman of…
Within one month of its implementation, the company or organisation informs the Director General of the Agence nationale de sécurité du médicament et des produits de santé, via a dedicated internet portal, of the appointment of a new responsible pharmacist as defined in Article L. 5124-2. The company or organisation shall send the competent central council of the national order of pharmacists, unless the person concerned is a pharmacist covered…
With a view to applying the rules laid down in the interests of public health, the pharmacist in charge defined in article R. 5124-34 assumes the following duties insofar as they correspond to the activities of the company or organisation in which he works: 1° He organises and supervises all the pharmaceutical operations of the company or organisation, and in particular the manufacture, advertising, information, pharmacovigilance, batch monitoring and withdrawal,…
If the duties of a pharmacist in charge are terminated or not renewed, the person concerned may refer the matter to the central council of the relevant section of the Ordre national des pharmaciens. After hearing both parties, the Council will issue an opinion as to whether or not the person concerned has failed to fulfil the obligations incumbent upon him, in the interests of public health, in his capacity…
For each establishment dependent on companies or organisations mentioned in 1°, 2° and 3° of Article R. 5124-2, the number of assistant pharmacists who assist and replace the pharmacist in charge or the delegated pharmacist, in accordance with the second paragraph of Article L. 5124-4 is set as follows, depending on the number of staff calculated under the conditions provided for in Article R. 5124-40: 1° One assistant pharmacist for…
For each establishment dependent on companies or organisations mentioned in 4° to 15° of article R. 5124-2, the number of assistant pharmacists who assist and replace the pharmacist in charge or the delegated pharmacist, in accordance with the second paragraph of article L. 5124-4 , is set as follows, depending on the number of staff calculated under the conditions provided for in article R. 5124-40: 1° One assistant pharmacist for…
For the purposes of calculating the number of staff referred to in Articles R. 5124-38 and R. 5124-39, account is taken of persons engaged in the following operations: 1° Manufacturing and import operations and all related controls ; 2° Warehousing, preparation of orders and packaging, and, in the case of gases for medical use, transport to the establishment’s storage tanks or premises referred to in Article R. 5124-7; 3° Batch…
When, for a period exceeding one month, an assistant pharmacist, recruited in application of articles R. 5124-38 or R. 5124-39, is absent or replaces the responsible or delegated pharmacist, he is replaced.
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75001, Paris France
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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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